NA 03.010.403Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982068552), received between Oct 27, 2017 and Oct 27, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2017Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING INITIAL INTRAMEDULLARY NAILING (TFN-ADVANCED) OF A FEMUR PROCEDURE ON (B)(6) 2017, AFTER THE SURGEON PREPPED THE PATIENT FOR THE NAIL, THE CERTIFIED SCRUB TECHNICIAN (CST) TESTED THE ALIGNMENT OF THE PERCUTANEOUS INSERTION HANDLE FOR FEMORAL NAILS AND A PERCUTANEOUS AIMING ARM (BOTH FOR LATERAL ENTRY FEMORAL NAILS) PRIOR TO THE CONTINUATION OF THE SURGERY. THE INSERTION HANDLE AND AIMING ARM DID NOT LINE UP WHILE USING ONLY A CANNULATED CONNECTING SCREW IN THE CONSTRUCT. THE SURGEON HAD TO SWITCH BACK TO THE STANDARD HANDLE (TFN; TROCHANTERIC FIXATION NAIL) TO COMPLETE THE PROCEDURE. THERE WAS 3 MINUTES DELAY IN SURGERY. PROCEDURE WAS COMPLETED SUCCESSFULLY AND PATIENT STATUS WAS REPORTED AS FINE. THIS COMPLAINT INVOLVES 2 DEVICES. CONCOMITANT DEVICES REPORTED: CANN CONNECTING SCR F/PERCUTANINSTRUMENTS FOR NAILS-EX (PART # 03.010.404, LOT # U238759, QUANTITY # 1). THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6984057 ↗
• MalfunctionOct 27, 2017Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING INITIAL INTRAMEDULLARY NAILING (TFN-ADVANCED) OF A FEMUR PROCEDURE ON (B)(6) 2017, AFTER THE SURGEON PREPPED THE PATIENT FOR THE NAIL, THE CERTIFIED SCRUB TECHNICIAN (CST) TESTED THE ALIGNMENT OF THE PERCUTANEOUS INSERTION HANDLE FOR FEMORAL NAILS AND A PERCUTANEOUS AIMING ARM (BOTH FOR LATERAL ENTRY FEMORAL NAILS) PRIOR TO THE CONTINUATION OF THE SURGERY. THE INSERTION HANDLE AND AIMING ARM DID NOT LINE UP WHILE USING ONLY A CANNULATED CONNECTING SCREW IN THE CONSTRUCT. THE SURGEON HAD TO SWITCH BACK TO THE STANDARD HANDLE (TFN; TROCHANTERIC FIXATION NAIL) TO COMPLETE THE PROCEDURE. THERE WAS 3 MINUTES DELAY IN SURGERY. PROCEDURE WAS COMPLETED SUCCESSFULLY AND PATIENT STATUS WAS REPORTED AS FINE. THIS COMPLAINT INVOLVES 2 DEVICES. CONCOMITANT DEVICES REPORTED: CANN CONNECTING SCR F/PERCUTANEOUS INSTRUMENTS FOR NAILS-EX (PART # 03.010.404, LOT # U238759, QUANTITY # 1). THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6984000 ↗